1. Field of the Invention
In the human body, blockages in blood vessels, arteries and the like often oppose the free flow of blood therein, one such blockage of which is thrombus. Thrombus is coagulated blood that is developed in vivo. Thrombus blocks blood flow to living tissue leading to ischemia and eventually tissue death. Depending on the end organ and the amount of blocked blood flow, the effects of thrombus can range from unnoticeable to death. Thrombus residing in a variety of native vessels and grafts can be treated. The occurrence and presence of thrombus occurs in several ways. First, it occurs in coronary procedures where thrombus is associated with myocardial infarction or heart attack. Thrombus is also common in older saphenous vein bypass grafts. Second, peripheral artery interventional procedures can encounter thrombus as well. The use of synthetic grafts and stents for the treatment of peripheral arterial disease can produce thrombus as a result of blood material interactions. Furthermore, thrombus can be formed resulting from the progression of the peripheral artery disease itself. As the artery becomes blocked with atherosclerotic material, thrombus can result as blood passes through the restricted diseased vessel. Venous thrombus can result from either vessel injury or hypercoagulable blood chemistry. Finally, interventional procedures themselves can create thrombus. Access to the patient's arterial vascular system is commonly accomplished via a femoral artery puncture. At the end of the procedure, the puncture site must be closed by either applying pressure until a natural thrombotic plug forms or using an arterial closure product which typically uses some sort of collagen plug or suture. In either case, thrombus can form at the puncture site and move down the femoral artery. Furthermore, during the interventional procedure itself, foreign materials such as catheters and guidewires are introduced into the patient's blood stream. The patient needs anticoagulants, typically heparin, to prevent the occurrence of thrombus. On occasion, inattention to activated clotting times can result in the occurrence of thrombus during the procedure. Third, other parts that have been treated by thrombectomy catheters include arterial-venous access grafts for hemodialysis patients. Thrombectomy catheters have proven effective in opening these grafts that occasionally become blocked with thrombus. Thrombectomy catheters have also been used in the venous system for deep vein thrombosis and occasionally in neurological venous applications. Finally, thrombectomy catheters have been clinically investigated in neurological arterial applications as well. In general, thrombectomy catheters have a potential application wherever thrombus forms in native arteries, veins and grafts. Having developed such thrombectomy catheters, there exists a need for a deployment system to allow simple and rapid use of a thrombectomy catheter and the devices supporting use of the thrombectomy catheter.
2. Description of the Prior Art
Current thrombectomy catheter utilization devices consist of a drive unit, disposable components including a variety of sterile thrombectomy catheters, a transportable sterile pump, bubble detectors, a saline supply tube/bag spike assembly, a nonsterile waste or effluent collection bag, and other associated components. Often, the use of such devices is overall cumbersome involving a large number of setup steps required for preparation and use. The current setup steps are roughly as follows (assuming the drive unit is on):                (1) open sterile package for the pump set;        (2) do a sterile exchange to hand off the catheter connection end of the pump supply line to the sterile technician;        (3) preclamp a Roberts clamp for the saline supply tube line;        (4) load the pump into the capture block while simultaneously loading the pump piston head into a reciprocating ram;        (5) spike a heparinized bag of saline;        (6) install the saline supply tube into an inlet bubble detector;        (7) unclamp the bag spike Roberts clamp to enable the pump to become primed;        (8) open the effluent collection bag packaging and remove the effluent collection bag;        (9) attach the effluent return tube to the proximal end of the pump supply line effluent connection;        (10) hang the effluent collection bag on the side of the drive unit;        (11) install the effluent waste tube through the roller pump;        (12) close the roller pump cover;        (13) push the effluent waste tube into the outlet bubble detector just proximal to the roller pump;        (14) select the catheter mode on the drive unit;        (15) open the catheter sterile packaging;        (16) do a sterile exchange to hand off the entire catheter to the sterile technician;        (17) connect the high pressure connection from the pump supply line to the catheter;        (18) connect the effluent Luer connection from the supply line to the catheter; and,        (19) submerge the catheter tip in a bowl of sterile saline and operate a drive unit foot switch to prime the catheter.        
Compare this to the pneumatically-operated thrombectomy catheter deployment system, the present invention, having a plurality of preconnected components wherein the setup consists of:                (1) opening a sterile package containing the pneumatically-operated thrombectomy catheter deployment system for the thrombectomy catheter;        (2) doing a sterile exchange to hand off the catheter portion to the sterile technician;        (3) attaching an air line to catheterization lab pressured gas source if the onboard compressed air tank is not utilized;        (4) spiking a heparinized saline bag;        (5) priming the pump; and,        (6) submerging the catheter tip in sterile saline and priming the catheter.        
Current generation drive units have been sequentiality built into the setup steps. The drive unit must turn on and go through self-test prior to placing the pump into the capture block. The pump must be loaded prior to spiking the saline supply bag, etc. Compare this to the instant invention wherein the pneumatically-operated thrombectomy catheter system, which is preconnected, requires no loading of a pump or connection of multiple components by tubing and the like except only for spiking of a saline supply bag. The only step that requires sequentiality is priming the catheter after the saline supply bag is spiked.
Current thrombectomy catheter utilization devices involve substantially a two-handed installation maneuver whereby a pump body is aligned within a capture block in the drive unit while a piston head of the pump is simultaneously loaded into a receptor in a reciprocating linear actuator. Each manual maneuver requires devoted attention and coordination by the operator. Contrast this to the pneumatically-operated thrombectomy catheter deployment system, the present invention, having preconnected components, wherein a preconnected drive unit, a preconnected thrombectomy catheter, and a preconnected effluent collection bag and preconnected compressed air tank, as well as preconnected tubing and the like, are simply placed on a medical equipment stand without any extraordinary effort by the operator.